Biological Matrix Supply Chain Shortages: More Matrices Are Now Rare—the Case for Surrogate Matrices

Author:

Dubiel Evan A.,Myler Heather,Arnold Mark E.,Bennett Patrick,Gatz Jeff,Groeber Elizabeth,Gupta Seema,Kane Cheikh,Li Fumin,Mylott William,Noah Courtney,O’Dell Mark,Tewalt Eric,Warrino Dominic,Vick Andrew

Publisher

Springer Science and Business Media LLC

Subject

Pharmaceutical Science

Reference21 articles.

1. Lavelle A, Micheli J. COVID-19’s impact on bioanalytical labs. Bioanalysis. 2021;13(15):1169–71. https://doi.org/10.4155/bio-2021-0103.

2. “US Food & Drug Administration Center for Drug Evaluation and Research”: Nonclinical considerations for mitigating nonhuman primate supply constraints arising from the COVID-19 pandemic. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/nonclinical-considerations-mitigating-nonhuman-primate-supply-constraints-arising-covid-19-pandemic (2022). Accessed Feb 2022.

3. “US Food & Drug Administration”: Blood specimen collection tube shortage: frequently asked questions. https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/blood-specimen-collection-tube-shortage-frequently-asked-questions (2022). Accessed February 2022.

4. Fogh JR, Jacobsen A-M, Nguyen TTTN, Rand KD, Olsen LR. Investigating surrogate cerebrospinal fluid matrix compositions for use in quantitative LC-MS analysis of therapeutic antibodies in the cerebrospinal fluid. Analytical and Bioanalytical Chemistry. 2020;412(7):1653–61. https://doi.org/10.1007/s00216-020-02403-3.

5. Li Y, Kang J, Lee Y, Chung JY, Cho JY. A validated simple LC-MS/MS method for quantifying trimethylamine N-oxide (TMAO) using a surrogate matrix and its clinical application. Transl Clin Pharmacol. 2021;29(4):216–25. https://doi.org/10.12793/tcp.2021.29.e19.

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